Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

COURT RULES FOR TEVA, RANBAXY IN GENERIC ZOCOR CASE

A federal judge has sided with Teva Pharmaceutical Industries and Ranbaxy Laboratories in their effort to get 80-day exclusivity when they begin marketing generic Zocor (simvastatin) tablets.

Teva and Ranbaxy each submitted citizens' petitions in early 2005 requesting that the FDA re-list the two simvastatin patents and give them the statutory 180-day exclusivity. The FDA denied the request in October of that year, but now the U.S. District Court for the District of Columbia has ruled that the FDA's action was "unlawful" and has sent it back to the agency for a decision, according to Teva.

Al Rauch, a financial analyst with AG Edwards & Sons, states that, should the FDA reverse its earlier decision, the exclusivity period could result in an additional $50 million in revenue for Teva this year.